In the years following FDA approval of direct-to-consumer, genetic-health-risk/DTCGHR testing, millions of people in the US have sent their DNA to companies to receive personal genome health risk information without physician or other learned medical professional involvement. In Personal Genome Medicine, Michael J. Malinowski examines the ethical, legal, and social implications of this development. Drawing from the past and present of medicine in the US, Malinowski applies law, policy, public and private sector practices, and governing norms to analyze the commercial personal genome sequencing and testing sectors and to assess their impact on the future of US medicine. Written in relatable and accessible language, the book also proposes regulatory reforms for government and medical professionals that will enable technological advancements while maintaining personal and public health standards.

One of the most significant factors that can shift, or bend, the trajectory of discovery is lobbying by patients. Patient advocacy organizations (PAOs), in their most modern form, emerged in the 1940s and 1950s as patients shared their experience of living with a disease - later morphing into self-help organizations. Over time, these groups have grown in stature and currently play a significant role in steering the direction of research. Additionally, the private sector is another important actor that can lobby for research agendas to be changed, either indirectly through patient organizations or by directly influencing policymakers. The way they achieve this, and the degree to which they succeed in redirecting the research trajectory, is the main focus of Chapter 13.